Sentinel Lymph Node BiopsyNCT04140188
SLNB After Nipple Sparing Mastectomy
A study testing Senti-Scint (99mTc- pertechnetate combined with human albumin) in people with Sentinel Lymph Node Biopsy and Mastectomy, Subcutaneous, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sentinel Lymph Node Biopsy, Mastectomy, Subcutaneous
- What is being tested?
- Senti-Scint (99mTc- pertechnetate combined with human albumin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2019to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: NSM with/without SLNB at least 6 months prior to this study -
Exclusion Criteria: previous axillary dissection and active breast cancer
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Maslak Hospital
Istanbul, Sariyer, 34457
Halil KARA, 5326073933, halil.kara@acibadem.edu.tr
Akif Enes Arikan, +905308222345, enes.arikan@acibadem.com.tr
About this study
Official title: Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study
Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.
Read the detailed description
Volunteer patients who has underwent to NSM at least more than 6 months prior will be included to the study. Radioisotope will be injected via intradermal route to the breast underwent to NSM patients and lymphoscintigraphy images will be obtained to detect activity in axilla. If hot nodule is detected then it will be concluded that SLNB can be performed after NSM.
- Being tested
- Senti-Scint (99mTc- pertechnetate combined with human albumin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senti-Scint (99mTc- pertechnetate combined with human albumin)Diagnostic test
Senti-Scint will be injected via intradermal route to the breast with history of previous NSM.
| Study group | Role | What they receive |
|---|---|---|
| Axilla no touch | Active comparator | Volunteer patients who did not underwent to SLNB or axillary lymph node dissection during previous NSM Receives: Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin) |
| Axilla with previous SLNB | Active comparator | Volunteer patients who has underwent to SLNB but not axillary lymph node dissection during previous NSM Receives: Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancement in axilla
Hot nodules will be showed in axilla after injection of SENTI-SCINT
Measured: 4 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph Node BiopsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil KARA, Acibadem University
- Investigators
- Halil KARA, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140188
- Sponsor's protocol ID
- RISA-19-01
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Intra M, Veronesi P, Gentilini OD, Trifiro G, Berrettini A, Cecilio R, Colleoni M, Rietjens M, Luini A, Paganelli G, Veronesi U. Sentinel lymph node biopsy is feasible even after total mastectomy. J Surg Oncol. 2007 Feb 1;95(2):175-9. doi: 10.1002/jso.20670.
PubMed 17262724Karam A, Stempel M, Cody HS 3rd, Port ER. Reoperative sentinel lymph node biopsy after previous mastectomy. J Am Coll Surg. 2008 Oct;207(4):543-8. doi: 10.1016/j.jamcollsurg.2008.06.139. Epub 2008 Jul 21.
PubMed 18926457
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy After Nipple Sparing Mastectomy: Prospective Study
- ClinicalTrials.gov ID
- NCT04140188
- Acronym / sponsor ID
- RISA-19-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.
Detailed description
Volunteer patients who has underwent to NSM at least more than 6 months prior will be included to the study. Radioisotope will be injected via intradermal route to the breast underwent to NSM patients and lymphoscintigraphy images will be obtained to detect activity in axilla. If hot nodule is detected then it will be concluded that SLNB can be performed after NSM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axilla no touch | Active comparator | Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin)Volunteer patients who did not underwent to SLNB or axillary lymph node dissection during previous NSM |
| Axilla with previous SLNB | Active comparator | Diagnostic Test: Senti-Scint (99mTc- pertechnetate combined with human albumin)Volunteer patients who has underwent to SLNB but not axillary lymph node dissection during previous NSM |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senti-Scint (99mTc- pertechnetate combined with human albumin)Senti-Scint will be injected via intradermal route to the breast with history of previous NSM. | Diagnostic test | Axilla no touch, Axilla with previous SLNB |
Primary outcome
Enhancement in axilla
Time frame: 4 hours after injection
Hot nodules will be showed in axilla after injection of SENTI-SCINT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Background: PubMed 17262724Intra M, Veronesi P, Gentilini OD, Trifiro G, Berrettini A, Cecilio R, Colleoni M, Rietjens M, Luini A, Paganelli G, Veronesi U. Sentinel lymph node biopsy is feasible even after total mastectomy. J Surg Oncol. 2007 Feb 1;95(2):175-9. doi: 10.1002/jso.20670.
- Background: PubMed 18926457Karam A, Stempel M, Cody HS 3rd, Port ER. Reoperative sentinel lymph node biopsy after previous mastectomy. J Am Coll Surg. 2008 Oct;207(4):543-8. doi: 10.1016/j.jamcollsurg.2008.06.139. Epub 2008 Jul 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halil KARA principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senti-Scint (99mTc- pertechnetate combined with human albumin) in people with Sentinel Lymph Node Biopsy and Mastectomy, Subcutaneous, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halil KARA (+905326073933, halil.kara@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhancement in axilla (time frame: 4 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04140188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019; AzTrials last refreshed its copy on 30 Oct 2026.